Broad Institute wins the legal battle over CRISPR patents

On 28th June 2012, a landmark paper published in Science by UC Berkeley structural Biologist Jennifer Doudna took the scientific world by storm, marking it as one of the “scientific breakthroughs of the century.” She and her colleague Emmanuelle Charpentier along with their team had discovered that CRISPR, an immune system used by bacteria to defend itself, could be used to modify genomes in any type of cell. Soon after, in May 2012 UC Berkeley filed for a patent for inventing CRISPR.

The seminal paper published by Doudna & her colleagues had described the use of CRISPR to cut DNA in vitro or in a test-tube. Later, in January 2013, a team in Broad Institute (which is affiliated with Harvard and MIT) headed by Dr Feng Zhang reported in a paper published in Science, that it had used CRISPR to cut DNA in human or eukaryotic cells, opening a new dimension for its use in medicine.

Broad applied for a dozen patents based on the eukaryotic applications of CRISPR and paid the U.S. Patent and Trademark Office (USPTO) for a fast-track review of the patents. This led to first of their patents getting approved in April 2014, truly marking the entry of the new technology into mainstream applications and stunning many researchers in this field.

This also marked the beginning of a fiercely contested, high stakes legal battle over the intellectual property of CRISPR invention. It was started by University of California, that appealed to the U.S. Patent Trial and Appeal Board about their claim to the invention and about how Broad researchers piggybacked on their discovery.

In a stunning ruling yesterday by the U.S. Patent Trial and Appeal Board, the patent court ruled in favor of Broad Institute at Cambridge, Massachusetts suggesting that there is “no interference in fact.” In other words, it suggests that the discoveries by the schools don’t actually overlap.

The PTAB justified its finding of “no interference in fact” by stating: “Broad has persuaded us that the parties claim patentably distinct subject matter.”

The Broad institute’s lawyers have argued consistently throughout the interference proceedings that UC’s patent application doesn’t specify how CRISPR-CAs9 editing could be used in eukaryotic cells such as mice or humans, which was clearly mentioned in Broad’s patents, thereby suggesting that the patents do not overlap. This line of reasoning could mean that the most lucrative applications of the CRISPR editing of eukaryotes such as plants and humans could go to Broad institute.

Responding to the patent board decision, a statement released by UC Berkeley, states that “We continue to maintain that the evidence overwhelmingly supports our position that the Doudna/Charpentier team was the first group to invent this technology for use in all settings and all cell types, and was the first to publish and file patent applications directed toward that invention, and that the Broad Institute’s patents directed toward use of the CRISPR-Cas9 system in particular cell types are not patentably distinct from the Doudna/Charpentier invention. For that reason, UC will carefully consider all options for possible next steps in this legal process, including the possibility of an appeal of the PTAB’s decision. We will be guided, as always, by the public’s best interest and will continue to support and advance fundamental research, such as CRISPR-Cas9, that can help solve our greatest challenges across human health, agriculture, and the environment.”

However, the ruling suggests that the inventions by both the research groups are separately patentable from one another, thereby moving the Doudna/Charpentier group’s application closer to issuance as a U.S. patent.

Says Paul Alivisatos, UC Berkeley vice chancellor for research and professor of chemistry, “UC respects today’s ‘no-interference-in-fact’ decision by the PTAB and is pleased that its patent application covering the use of CRISPR-Cas9 gene editing technology for all cell types can now move closer to issuance”.

In a teleconference for the media held by UC, Doudna emphasized that the ruling of “no interference” implied that USPTO will now move forward on her patent application and could “likely” be issued. “They have a patent on green tennis balls. We [likely] will have a patent on all tennis balls,” says Doudna.

However, the PTAB ruling is clearly a win for the Broad Institute which was hoping for the finding of no interference. This will allow the institute to retain its patents to use CRISPR technology on human and animal cells.

Co-founder, Author and Editor, biotechin.asia, Biotech Media Pte. Ltd.
Laxmi graduated from University of Mumbai, India (Bachelors in Biotechnology and Biochemistry and Masters in Biochemistry) in 2007 and received her Ph.D in Virology from Nanyang Technological University, Singapore. She worked on the process of assembly of respiratory syncytial virus in macrophages and epithelial cells and has several papers to her credit.